Oxcarbazepine (Trileptal)

Trade Name : Trileptal

Novartis Pharmaceuticals Corporation

TABLET, FILM COATED

Strength 300 mg/1

OXCARBAZEPINE Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Oxcarbazepine (Trileptal) which is also known as Trileptal and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 300 mg/1 per ml. Read more

Oxcarbazepine (Trileptal) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • TRILEPTAL is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.
  • TRILEPTAL isu00a0indicated for:
  • Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures n
  • Pediatrics: - Monotherapy in the treatment of partial-onset seizures in children 4u201316 years - Adjunctive therapy in the treatment of partial-onset seizures in children 2u201316 years ()
  • Adults:
  • Film-n- cn- oated Tablets:
  • Oral Suspension:n- u00a0
  • Film-coated tablets: 150 mg, 300 mg and 600 mg ()n
  • Oral suspension: 300 mg/5 mL (60u00a0mg/mL) ()
  • TRILEPTAL is contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate [].t
  • Known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate (, )
  • No data
  • Hyponatremia: Monitor serum sodium levelsu00a0()n
  • Cross Hypersensitivity Reaction to Carbamazepine: Discontinue immediately if hypersensitivity occurs ()n
  • Serious Dermatological Reactions: If occurs, consider discontinuation ()n
  • Suicidal Behavior and Ideation: Monitor for suicidal thoughts/behavioru00a0()n
  • Withdrawal of AEDs: u00a0Withdraw TRILEPTALgraduallyu00a0()n
  • Cognitive/Neuropsychiatric Adverse Reactions: May cause cognitive dysfunction, somnolence, and coordination abnormalities. Use caution when operating machineryu00a0()n
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity: Monitor and discontinue if another cause cannot be established ()n
  • Hematologic Events: Consider discontinuing ()n
  • Seizure Control During Pregnancy:u00a0Active metabolite may decreaseu00a0()n
  • Risk of Seizure Aggravation: Discontinue if occursu00a0()
  • The following serious adverse reactions are described below and elsewhere in the labeling:
  • The most common (u2265 10% more than placebo for adjunctive or low dose for monotherapy) adverse reactionsu00a0in adults and pediatrics were: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, headache, nystagmus, tremor, and abnormal gait. ()
  • nttttttttttTo report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or .
  • No data
  • Phenytoin:u00a0Increased phenytoin levels. Reduced dose of phenytoin may be requiredu00a0()n
  • Carbamazepine, Phenytoin, and Phenobarbital:u00a0Decreased plasma levels of MHD (the active metabolite). Dose adjustments may be necessary ()n
  • Oral Contraceptive:u00a0TRILEPTAL may decrease the effectiveness of hormonal contraceptivesu00a0()
  • No data
  • Pregnancy: May cause fetal harm (n n
  • No data
  • No data
  • TRILEPTAL is an antiepileptic drug available as 150 mg, 300 mg, and 600 mg film-coated tablets for oral administration. TRILEPTAL is also available as a 300 mg/5 mL (60u00a0mg/mL) oral suspension. Oxcarbazepine is 10,11-Dihydro-10-oxo-5-dibenz[b,]azepine-5-carboxamide, and its structural formula is:
  • Oxcarbazepine is a white to faintly orange crystalline powder. It is slightly soluble in chloroform, dichloromethane, acetone, and methanol and practically insoluble in ethanol, ether and water. Its molecular weight is 252.27 g/mol.
  • TRILEPTAL film-coated tablets contain the following inactive ingredients:u00a0colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.
  • TRILEPTAL oral suspension contains the following inactive ingredients:u00a0ascorbic acid; dispersible cellulose; ethanol; macrogol stearate; methyl parahydroxybenzoate; propylene glycol; propyl parahydroxybenzoate; purified water; sodium saccharin; sorbic acid; sorbitol; yellow-plum-lemon aroma.
  • No data
  • Carcinogenesis
  • In 2-year carcinogenicity studies, oxcarbazepine was administered in the diet at doses of up to 100 mg/kg/day to mice and by gavage at doses of up to 250 mg/kg/day to rats, and the pharmacologically active 10-hydroxy metabolite (MHD) was administered orally at doses of up to 600 mg/kg/day to rats. In mice, a dose-related increase in the incidence of hepatocellular adenomas was observed at oxcarbazepine doses u2265 70 mg/kg/day, which is less than the maximum recommended human dose (MRHD) on a mg/m basis. In rats, the incidence of hepatocellular carcinomas was increased in females treated with oxcarbazepine at doses u2265 25u00a0mg/kg/day (less than the MRHD on a mg/m basis), and incidences of hepatocellular adenomas and/or carcinomas were increased in males and females treated with MHD at doses of 600 mg/kg/day (2.4 times the MRHD on a mg/m basis) and u2265 250 mg/kg/day (equivalent to the MRHD on a mg/m basis), respectively. There was an increase in the incidence of benign testicular interstitial cell tumors in rats at 250 mg oxcarbazepine/kg/day and at u2265 250 mg MHD/kg/day, and an increase in the incidence of granular cell tumors in the cervix and vagina in rats at 600 mg MHD/kg/day.
  • Mutagenesis
  • Oxcarbazepine increased mutation frequencies in the Ames test in the absence of metabolic activation. Both oxcarbazepine and MHD produced increases in chromosomal aberrations and polyploidy in the Chinese hamster ovary assay in the absence of metabolic activation. MHD was negative in the Ames test, and no mutagenic or clastogenic activity was found with either oxcarbazepine or MHD in V79 Chinese hamster cells in vitro. Oxcarbazepine and MHD were both negative for clastogenic or aneugenic effects (micronucleus formation) in an in vivo rat bone marrow assay.
  • Impairment of Fertility
  • In a study in which male and female rats were administered oxcarbazepine (0, 25, 75, and 150 mg/kg/day) orally prior to and during mating and continuing in females during gestation, no adverse effects on fertility or reproductive performance were observed. The highest dose tested is less than the MRHD on a mg/m basis. In a fertility study in which rats were administered MHD (0, 50, 150, or 450 mg/kg/day) orally prior to and during mating and early gestation, estrous cyclicity was disrupted and numbers of corpora lutea, implantations, and live embryos were reduced in females receiving the highest dose (approximately 2 times the MRHD on a mg/m basis).
  • The effectiveness of TRILEPTAL as adjunctive and monotherapy for partial-onset seizures in adults, and as adjunctive therapy in children aged 2 to 16 years was established in seven multicenter, randomized, controlled trials.
  • The effectiveness of TRILEPTAL as monotherapy for partial-onset seizures in children aged 4 to 16 years was determined from data obtained in the studies described, as well as by pharmacokinetic/pharmacodynamic considerations.
  • Tablets
  • 150 mg Film-Coated Tablets:
  • Bottle of 100u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026...NDC 0078-0456-05
  • Unit Dose (blister pack)
  • Box of 100 (strips of 10)u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026....NDC 0078-0456-35
  • 300 mg Film-Coated Tablets:n- u00a0u00a0
  • Bottle of 100u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026...NDC 0078-0337-05
  • Unit Dose (blister pack)
  • Box of 100 (strips of 10)u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026NDC 0078-0337-06
  • 600 mg Film-Coated Tablets:
  • Bottle of 100u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026...NDC 0078-0457-05
  • Unit Dose (blister pack)
  • Box of 100 (strips of 10)u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026NDC 0078-0457-35
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).
  • Suspension
  • 300 mg/5 mL (60 mg/mL) Oral Suspension:
  • Bottle containing 250 mL of oral suspensionu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026NDC 0078-0357-52
  • Store TRILEPTALu00a0oral suspension in the original container. Shake well before using.
  • Use within 7 weeks of first opening the bottle.
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature].
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Administration Information
  • Counsel patients that TRILEPTAL may be taken with or without food.
  • For TRILEPTAL oral suspension, advise patients to shake the bottle well and prepare the dose immediately afterwards using the oral dosing syringe supplied. Inform patients that TRILEPTAL oral suspension can be mixed in a small glass of water just prior to administration or, alternatively, may be swallowed directly from the syringe. Instruct patients to discard any unused TRILEPTAL oral suspension after 7 weeks of first opening the bottle [n n n ]n
  • Hyponatremia
  • Advise patients that TRILEPTAL may reduce the serum sodium concentrations especially if they are taking other medications that can lower sodium.u00a0Instruct patients to report symptoms of low sodium like nausea, tiredness, lack of energy, confusion, and more frequent or more severe seizures [].
  • Anaphylactic Reactions and Angioedema
  • Anaphylactic reactions and angioedema may occur during treatment with TRILEPTAL.u00a0Advise patients to report immediately signs and symptoms suggesting angioedema (swelling of the face, eyes, lips, tongue or difficulty in swallowing or breathing) and to stop taking the drug until they have consulted with their physician [].
  • Crossn- Hypersensitivity Reaction to Carbamazepine
  • Inform patients who have exhibited hypersensitivity reactions to carbamazepine that approximately 25% to 30% of these patients may experience hypersensitivity reactions with TRILEPTAL. Patients should be advised that if they experience a hypersensitivity reaction while taking TRILEPTAL they should consult with their physician immediately [].
  • Serious Dermatological Reactions
  • Advise patients that serious skin reactions have been reported in association with TRILEPTAL. In the event a skin reaction should occur while taking TRILEPTAL, patients should consult with their physician immediately [].
  • Suicidal Behavior and Ideation
  • Patients, their caregivers, and families should be counseled that AEDs, including TRILEPTAL, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providersu00a0.
  • Driving and Operating Machinery
  • Advise patients that TRILEPTAL may cause adverse reactions such as dizziness, somnolence, ataxia, visual disturbances, and depressed level of consciousness. Accordingly, advise patients not to drive or operate machinery until they have gained sufficient experience on TRILEPTAL to gauge whether it adversely affects their ability to drive or operate machinery .
  • Instruct patients that a fever associated with other organ system involvement (e.g., rash, lymphadenopathy, hepatic dysfunction) may be drug-related and should be reported to their healthcare provider immediately [].
  • Hematologic Events
  • Advise patients that there have been rare reports of blood disorders reported in patients treated with TRILEPTAL. Instruct patients to immediately consult with their physician if they experience symptoms suggestive of blood disorders [].
  • Drug Interactions
  • Caution female patients of reproductive potential that the concurrent use of TRILEPTAL with hormonal contraceptives may render this method of contraception less effective . Additional non-hormonal forms of contraception are recommended when using TRILEPTAL.
  • Caution should be exercised if alcohol is taken in combination with TRILEPTAL, due to a possible additive sedative effect.
  • Pregnancy Registry
  • Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy [n n ].
  • T2019-01
  • No data
  • Trileptaln
  • Oral Suspensionu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n n n
  • Instructions for Use
  • Read these instructions carefully to learn how to use the medicine dispensing system correctly.
  • Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
  • T2018-33March 2018
  • u00a9 Novartis
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 150 mg
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0456-05
  • Trileptal (oxcarbazepine)
  • 100 tablets
  • PHARMACIST: DISPENSE WITH MEDICATION GUIDE ATTACHED OR PROVIDED SEPARATELY.
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 300 mg
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0337-05
  • Trileptal (oxcarbazepine)
  • 100 tablets
  • PHARMACIST: DISPENSE WITH MEDICATION GUIDE ATTACHED OR PROVIDED SEPARATELY.
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 600 mg
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0457-05
  • Trileptalu00ae (oxcarbazepine)
  • 100 tablets
  • PHARMACIST: DISPENSE WITH MEDICATION GUIDE ATTACHED OR PROVIDED SEPARATELY.
  • PRINCIPAL DISPLAY PANEL
  • Package Label u2013 n- 300 mg / 5 n- mL
  • Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0357-52
  • Trileptalu00ae Oral Suspension
  • (oxcarbazepine)
  • 250 mL
  • IMPORTANT: Shake well before using.
  • Each 5 mL contains 300 mg oxcarbazepine.
  • PHARMACIST: DISPENSE WITH MEDICATION GUIDE ENCLOSED OR PROVIDED SEPARATELY.

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